The company develops comprehensive strategies to ensure a product’s lifecycle meets the regulatory requirements of the health and food industries in Canada.

Preparation of medical device regulatory applications

RAQAC’s consultants combine their experience with Canadian authorities and their knowledge of the product process to provide guidance for submitting market approval applications.

A cost-effective market-access plan is developed, which aims to ensure compliance with stringent regulatory and quality industry standards in a timely manner.

Regulatory affairs management

RAQAC’s provides a regulatory affairs service to ensure all necessary documentation is collected in preparation for submitting a marketing approval application for medical devices from class 2 through to class 4.

The firm’s knowledge of Canadian regulation extends to the food, drug, cosmetic, medical device and NHP industries.

The company organises product submissions for natural health product licence applications (PLA), drug identification number submissions, export certificates to Canadian manufacturers and cosmetics notifications, and government filings.

Good manufacturing practice (GMP) production and quality management

RAQAC offers a number of audits to identify potential issues for pharmaceutical, food and cosmetic product manufacturers, importers and distributors regarding market approval applications in Canada. The company offers innovative solutions, including the management of quality assurance and manufacturing processes.

Its medical device services include:

Audit preparation, representation and follow-up

Transportation carrier selection and cold chain

Electrical safety considerations

International Standards Organisation (ISO) registrar selection, implementation and support

Medical Device Single Audit (MDSAP) requirements

Medical device establishment licensing support

Recalls and complaint management

Standard operating procedure (SOP) implementation

The company also helps manufacturers meet good manufacturing practice (GMP) standards.

Project management services

RAQAC provides a comprehensive project management service to support regulatory applications. Its project managers implement cost-effective plans to meet key timelines and support regulatory initiatives.

Cross-functional departments are taken into consideration to ensure projects such as product launches, line extensions and changes in manufacturing processes are carried out with minimal downtime.